EP4134122A1 - Fluid application instrument and clamping device - Google Patents

Abstract

According to the concept of the invention, a kinked hose valve is provided for generating a high-pressure pulse, which includes a loop (12) provided in the supply hose (fluid hose (5)) of an instrument (2) and a hose buckling device (8) provided as a reusable component. Such a valve has a very simple design and allows the generation of very steep pressure rise flanks at very high pressures of up to 100 bar, as are required for needle-free injection. The sterilization effort is minimal. Likewise, the cost of materials is minimal when using disposable components.

Description

The invention relates to an instrument for fluid application and a hose bending device for pinching off and releasing a fluid hose.

From the EP 3 714 926 A1 an application system is known with the help of which medical fluids can be introduced into biological tissue without a needle. For this purpose, a first fluid channel is provided in the instrument, via which a sharp jet of a fluid can be emitted, which is used to open an injection channel in the tissue. The medical fluid, for example a liquid containing living cells, is introduced at a lower pressure via a further fluid channel and can then penetrate into the tissue through the opened injection channel.

In order to deliver a sharp jet of fluid to efficiently open the injection channel in the biological tissue, it is important that the rise in the fluid pressure at the distal end of the instrument at the beginning of the delivery of a sharp injection jet is as steep as possible. This is to ensure that the jet generated has its full penetration capacity right from the start and that as little liquid as possible is deposited in the layers in front of the target tissue and thus does not reach the target tissue.

The EP 3 040 101 B1 discloses a device for generating the steepest possible pressure rise flanks. For the Valves are provided for blocking and releasing pressurized fluid channels. These must either be designed to be sterilizable as a whole or they must be designed as single-use components.

Irrespective of this, they must in any case be suitable for being able to suddenly release or block a considerable fluid pressure of up to 100 bar.

So-called pinch valves are known for opening and releasing fluid channels. An example reveals the U.S. 9,095,656 B2 . The pinch valve described there is formed by a flexible line section which is arranged inside a pressure vessel. This pressure vessel also serves as an energy source for generating a fluid jet. By arranging a flexible hose in the pressure vessel, the pressure inside the line is always approximately the same as that outside the supply line. Thus, the valve drive only has to overcome the restoring force of the wall of the flexible line element. This results in only low closing forces. The fluid channel is released by the restoring force of the wall and is supported only slightly by the fluid pressure due to the small pressure difference between the pressure inside the fluid channel and the pressure outside the hose. This can reduce the steepness of the pressure rise when opening the valve.

So-called kink valves are also known. To this end, the U.S. 2,540,364 a hose with several finger loops. The finger loops can be slipped onto the fingers and thumb of an operator's hand, who can then, with a simple flick of the wrist, kink or release the hose.

Other mechanized devices for kinking and releasing a tube are known from US Pat GB 1 012 565 , the DE 698 15 825 T2 , the EP 2 133 610 A1 or the EP 2 130 562 A2 known.

The DE 60 2004 009 494 T2 discloses a device which, by means of two eccentric discs on a hose, defines a plurality of kinks which are arranged one behind the other and which form valves. These kinks or valves are alternately opened and closed by cam disks in order to let out small portions of fluid from a high-pressure fluid reservoir and to output them at low pressure. A simple magnetically actuated kink valve also reveals the U.S. 6,056,260 .

The object of the invention is to specify a concept for an instrument and an associated valve with which a fluid under high pressure can be delivered in pulses with a steep pressure rise flank and which requires only little effort.

This task is solved on the one hand with the instrument according to claim 1 and on the other hand with the hose bending device according to claim 9:

According to the invention, the instrument has a first fluid hose that can be connected to a first fluid source in order to supply the instrument with fluid that is under high pressure. The first fluid tube of the instrument itself is used as a valve. For this purpose, it is introduced into a hose kinking device according to claim 9, which has an actuating device in order to kink off or release a loop formed by the fluid hose in a targeted manner. To facilitate the insertion of a Loop of the fluid hose in the hose kink device, a holder can be arranged on the fluid hose according to claim 1 to hold the fluid hose in a loop. The loop can then be handled like a plug and inserted into a corresponding channel of the hose bending device. This concept separates the instrument-side components that are easy to sterilize or can always be newly provided with little effort and can therefore be provided as single-use parts from device-side components that cannot be sterilized or are difficult to sterilize and can only be newly provided with great effort. Each kink valve is thus formed overall by a device-side component, namely the hose kink device, and by the first fluid hose of the instrument.

The fluid supplied to the instrument via the first fluid hose can be under high pressure and can be supplied in pulses, each with a steep pressure rise flank, in order to form an injection channel in the biological tissue. The instrument can have a second fluid hose, the proximal end of which can be connected to a second fluid source. This can be under a different pressure, in particular a lower pressure, in order to deliver medical fluid after the injection channel has been opened, which fluid is introduced by the instrument or the fluid applicator into the opened injection channel and thus into the biological tissue.

While the first fluid hose is held in a loop by the holder in order to be introduced into the hose bending device, the second fluid hose is preferably designed or guided without kinks or loops. However, it is also possible to route the second fluid hose through a hose kink device in order to use its kink as a valve.

The loop fixed by the holder preferably has two legs which are held approximately parallel to one another by the holder. The length L of the loop, in particular the length of its legs, is preferably greater than the distance between the two legs, which determines its width B. The length L and the width B are matched to one another in such a way that the loop is open when at rest. It kinks and thus closes with only one kink when the width B is reduced by the hose kink device.

The holder is preferably fixed on the first fluid hose, that is, arranged so that it cannot be displaced. The holder thus determines the size of the loop and thus also the position of the loop relative to the actuating device of the hose kink device as soon as the holder with the loop is plugged into the channel of the hose kink device like a plug. Proper function is thus ensured.

Instead of the holder, however, other means for limiting the insertion depth of the loop into the channel can also be provided. For example, a stop means, for example a wall, can be provided behind the actuating device in the insertion direction, against which the loop abuts when it is pushed into the channel. In this case, this wall forms a positioning means for fixing the position of the loop relative to the actuator. In such hose kink devices can Sections of a fluid hose that are formed into a loop by hand and that do not have a holder can also be inserted. Instruments that are not designed according to claim 1 can also be used in conjunction with the hose kink device according to claim 8 .

In the case of tube bending devices which lack such a positioning means as mentioned above, the holder provided on the first fluid tube of the instrument can take over the function of this positioning means. The holder then rests against a wall in front of the actuating device in the direction of insertion, which as a plug stop also limits the insertion depth of the loop.

• Figur 1 eine Behandlungseinrichtung mit einem Instrument und einer Schlauchknickeinrichtung gemäß der Erfindung,
• Figur 2 die Schlauchknickeinrichtung und einen Teil des Fluidschlauchs des Instruments nach Figur 1 in ausschnittsweiser schematisierter Darstellung,
• Figur 3 den Fluidschlauch und die Schlauchnickeinrichtung nach Figur 2 in perspektivischer getrennter Darstellung,
• Figur 4 die Anordnung nach Figur 2 in perspektivischer Darstellung,
• Figur 5 eine etwas abgewandelte Ausführungsform einer Schlauchknickeinrichtung mit Fluidschlauch in offenem Zustand,
• Figur 6 die Schlauchknickeinrichtung nach Figur 5 und den Fluidschlauch des Instruments in geschlossenem Zustand,
• Figur 7 eine abgewandelte Ausführungsform der Schlauchknickeinrichtung bei geschlossenem Fluidschlauch,
• Figur 8 die Schlauchknickeinrichtung nach Figur 7 bei offenem Fluidschlauch,
• Figur 9 eine abgewandelte Ausführungsform eines Instruments sowie eines versorgenden Geräts mit Schlauchknickeinrichtung in perspektivischer Darstellung,
• Figur 10 ein Instrument mit Schlauchknickeinrichtung in schematisierter Darstellung und
• Figur 11 eine abgewandelte Ausführungsform der Schlauchknickeinrichtung.

Further details of advantageous embodiments of the invention are the subject matter of the figures of the drawing, the associated description and the dependent claims. Show it:

• figure 1 a treatment device with an instrument and a hose kink device according to the invention,
• figure 2 the hose kink assembly and part of the fluid hose of the instrument figure 1 in a partial schematic representation,
• figure 3 the fluid hose and the hose nodding device figure 2 in a perspective separate representation,
• figure 4 according to the arrangement figure 2 in perspective view,
• figure 5 a slightly modified embodiment of a hose kink device with a fluid hose in the open state,
• figure 6 the hose kink device figure 5 and the fluid hose of the instrument in a closed state,
• figure 7 a modified embodiment of the hose bending device with the fluid hose closed,
• figure 8 the hose kink device figure 7 with an open fluid hose,
• figure 9 a modified embodiment of an instrument and a supplying device with a hose kink device in a perspective view,
• figure 10 an instrument with hose kink device in a schematic representation and
• figure 11 a modified embodiment of the hose kink device.

In figure 1 a device 1 for treating a patient by injecting medical liquid is illustrated. The device 1 includes an instrument 2 to be guided, for example, by hand, and other devices and structural units for supplying the instrument 2 with one or more liquids. These assemblies include at least a first fluid source 3, for example containing fluid under high pressure, for example sodium chloride solution. The pressure is sufficiently high to supply a fluid applicator provided on the instrument 2 with fluid under injection pressure. The injection pressure is so high that a fluid jet emerging from the fluid applicator 4 penetrates into biological tissue and opens an injection channel there. In addition to physiological saline, the fluid source 3 can also contain and provide other biologically compatible fluids.

The instrument 2 is or can be connected to the fluid source 3 via a first fluid hose 5 . For this purpose, the fluid hose 5 can be provided with a plug 6 at its proximal end. Its distal end, on the other hand, is preferably firmly connected to the instrument 2, but if necessary it can also be detachably connected.

The fluid source 3 can be set up to permanently deliver pressurized fluid to the instrument 2 via the plug 6 . However, the fluid source 3 can also contain valves or other control elements in order to selectively release or block the pressurized fluid. A control device 7 can be provided for controlling the fluid source 3 .

The fluid applicator 4 requires the fluid that is supplied by the fluid source 3 and is under high pressure, preferably in pulses with steep pressure rise flanks. To provide and generate such pressure pulses, a hose bending device 8 is provided, which can be controlled by the control device 7 . The hose kink device 8 forms, together with a section of the fluid hose 5, a high-pressure valve for blocking and releasing the fluid in the fluid hose 5.

The instrument 2 can be connected via a second fluid tube 9 to a second fluid source 10 which provides a second fluid, in particular a fluid used as a medication, a cell suspension or the like. The second fluid source can provide the fluid at a lower pressure continuously or in pulses. The second fluid source 10 can contain a valve and be controlled by the control device 7 in order to control the fluid delivery. The fluid hose 9 can be connected to the fluid source 10 via a plug 9a.

The hose kink device 8 and the fluid hose 5 together form a high-pressure valve that figure 2 is illustrated in principle. The fluid hose 5 consists of a suitable, customary plastic, such as PU, PFA, FEP, KPFA, KEEP, PVC, silicone, PA, TPE-S or any other suitable plastic. Fiber-reinforced or reinforced plastic hoses can be used.

The hose 5 is held in a holder 11 which, as figure 1 can be seen, is preferably arranged in the vicinity of the plug 6 between the proximal and the distal end of the fluid tube 5. The holder is 11 fixedly attached to the fluid hose 5 to hold a portion of the hose 5 in a loop 12 . This loop has two legs 13 , 14 which are essentially parallel to one another and merge into one another at a loop head 15 . The fluid hose has such a rigidity that when the two legs 13, 14 are moved towards one another, it buckles at the point with the greatest curvature, namely at the loop head 15, blocking its lumen without the lumen being bent elsewhere collapsed by crushing.

The holder 11 together with the loop 12 forms a plug. The loop 12 of the plug formed in this way can be inserted into an in figure 2 Introduce the plug-in area 16 shown as a dashed line. A slit-like opening 17 formed in a front wall 18 of the hose bending device 8 forms the entrance of the insertion area 16 . The wall 18 is thus at the same time a positioning means 19 for the plug or the holder 11. Pins 20, 21 can be provided on the holder 11, which fit into corresponding openings in the wall 18 in order to fix the holder 11 on the wall 18 and to position. Instead of the pins 20, 21, other connecting and positioning means can also be provided, for example permanent magnets or other mechanical or non-mechanical latching means.

The tuck-in area 16 is the space occupied by the loop 12 in the relaxed state. It extends through an actuating device 22 which is suitable for moving the legs 13, 14 towards one another against their own spring tension. In this case, the actuating device is preferably closer to the loop head 15 than on the holder 11. The actuating device 22 may comprise a movable element 23 suitable for urging the leg 14 in the direction of the leg 13. Correspondingly, the element 23 can be connected to a drive device 24 . The element 23 can be arranged to be linearly movable or also to be pivotally movable.

A further element 25 can be arranged opposite the element 23 and can be designed as a fixed abutment. Alternatively, the element 25 can also be arranged so that it can move counter to the element 23 and can be connected to a corresponding drive device (not shown).

figure 3 illustrates the in figure 2 presented situation again in perspective. As can be seen, the insertion area 16 is in turn separated from the opening 17 and a corresponding opening between the element 25 serving as an abutment and the in figure 3 formed by the drive device 24 concealed movable element 23.

figure 4 FIG. 12 shows the loop 12 inserted into the hose kink device 8. The holder 11 rests against the wall 18. FIG. The loop 12 extends through the actuator 22. The loop head 15 is behind the actuator 22 as viewed from the wall 18.

In the embodiment described so far, the holder 11 determines the insertion depth of the loop 12 into the hose kink device 8. The wall 18 is thus (together with the holder 11) the positioning means for the loop 12.

However, it is also possible to set the insertion depth of the loop 12 by a stop 26 for the loop head 15, as shown in FIG Figure 5 and 6 emerges. The stop 26 then in turn forms the positioning means 19. With such an embodiment of the hose bending device 8, the holder 11 can be omitted or the holder 11 can be arranged at a greater distance from the front wall 18. Holders 11 can also be used which are not stationary on the fluid hose 5 but are arranged such that they can be repositioned (eg, slidably).

The drive device 24 can be designed as a magnetic drive. For example, a coil 27 can be provided for this purpose, in the middle of which an armature 28 is arranged, which is firmly connected to the movable element 23 . A spring 29 can then be used to keep the armature 28 and with it the element 23 in the rest position outside of the insertion area 16 .

The actuator 22 and the loop 12 together form a valve. The fluid side part of the valve is formed by the loop 12 belonging to the instrument 2. The part of the valve that is not touched by the fluid is formed by the hose kink device 8 , which can be configured as a separate device or can belong to a device that includes the control device 7 and the fluid source 3 and 10 .

To inject fluid into biological tissue, the device 1 described so far works as follows:

After the instrument 2 has been connected to the fluid sources 3 and 10, the plug formed from the holder 11 and the loop 12 is inserted into the hose bending device 8 inserted as is the figure 2 , 4 or 5 illustrated. Thus, the device 1 is basically ready to work.

After switching on the control device 7, the control device 7 detects the correct connection of the instrument 2 to the fluid sources 2, 10 and the insertion of the loop 12 into the hose kink device 8. The control device 7 now closes the valve formed from the loop 12 and the hose kink device 8, How figure 6 illustrated by the coil 27 is energized. As a result, the armature 28 is drawn into the coil 27 and the element 23 is thus pushed against the element 25 serving as an abutment. The two legs 13, 14 are moved toward one another, so that the fluid hose 5 bends at the hose head 15. In this state, the fluid channel is shut off and no high-pressure fluid can penetrate to the instrument 2 .

The abutment 24 is preferably arranged in such a way that the leg 13 remains essentially undeformed. The path of movement of the element 23 is preferably determined such that, in the retracted state, it leaves the cross-section of the leg 14 substantially undeformed and, when it is moved maximally towards the abutment 24, maintains a distance therefrom. The distance is preferably at least twice the diameter of the fluid hose 5. This prevents the fluid hose 5 from being squeezed. In other words, the hose cross-section remains essentially circular in the area of the actuating device, its lumen is open (not pinched) here.

Before this valve is closed, the fluid tube 5 can be flushed with fluid in order to eliminate air present in the fluid tube 5 and in the instrument 2 and the applicator 4 . For this purpose, before the valve formed by the loop 12 is closed, the control device releases fluid from the fluid source 3, preferably at reduced pressure, for a short time.

If a medical treatment fluid is now to be applied to a patient, the fluid 3, which is under high pressure, is first used by the instrument 2 and the fluid applicator 4 to open an injection channel. For this purpose, the control device 7 briefly de-energizes the coil 27 . As a result, the armature 28 is no longer attracted. The spring 29 urges the armature 28 out of the coil 27, bringing the position down figure 5 is reached. The kink at the loop head 15 is eliminated and fluid at high pressure suddenly reaches the fluid applicator 4. The high fluid pressure supports the hose in its opening movement. The fluid applicator 4 emits a sharp jet of fluid that can open an injection channel in biological tissue.

Although an extremely steep pressure rise can already be achieved on the fluid applicator 4 with this concept, the pressure rise can be made even steeper. If the armature 28 is designed as a permanent-magnetic armature, for example, moving the movable element 23 out of the insertion area 16 can be accelerated even more by not de-energizing the coil 27 to open the valve, but energizing it with the reverse polarity. A spring acting between the legs 13, 14 can also accelerate the pivoting of the legs 13, 14 apart.

Another efficient way to do this is illustrated Figure 7 and Figure 8 . The moving element 23 is here actuated by a cam 30 which may have one or more cams. For example, the circumference of the cam disk 30 can follow a spiral and have a recess 31 at the end of the same. The cam disk 30 can have its spiral periphery in abutment with the movable element 23 which works as a cam follower. A suitable spring means, for example the spring 29 designed as a leaf spring, keeps the movable element 23 in contact with the cam disk 30 .

For example, a suitable motor, for example a stepping motor, is provided for closing the valve, which motor rotates the cam disk 30 until the element 23 has reached the highest point of the circumference of the cam disk 30 . If the valve is now to be opened, the stepper motor rotates the cam disk 30 as figure 8 FIG. 12 further illustrates such that the moveable element 23 reaches and exceeds the recess 31. FIG. Under the action of the resilience of the branches 13 and 14 of the loop 12 and under the action of the spring 29, the element 23 springs into its rest position practically instantaneously, so that the valve opens at the greatest possible speed.

A further variant of the actuating device 22 is illustrated figure 11 . There, the anchor 28 has a slot whose width is slightly larger than the diameter of the fluid hose 5 and thus allows the lateral guidance of the loop 12 on the one hand, but also the movement of the hose in the opening and closing direction on the other hand. The anchor 28 thus defines part of the insertion area 16.

The spring 29 urges the armature 18 into the release position shown. When the coil 27 is energized, the armature 28 in figure 11 pulled down so that the loop 12 bends on the tube head 15. Otherwise, the description of the previous exemplary embodiments applies accordingly.

figure 9 FIG. 12 illustrates a device 32 that combines both the fluid sources 3 and 10 as well as the hose kink device. The holder 11 summarizes the loop 12 in a partial housing 11a, which also has a contact surface for one of the two legs 13 or 14. Opposite the contact surface, the partial housing 11a has an opening through which a ram can penetrate into the partial housing 11a in order to bend the loop 12. The tappet can in turn be formed by a movable element 23 which is actuated by a suitable actuator, for example an electromagnet or a cam disk. A spring means can be arranged in the partial housing 11a, which is arranged between the legs 13, 14 and acts on the leg 14. The spring means can apply a force that counteracts the buckling of the tube head.

To accommodate the partial housing 11a in the hose bending device, it has a receiving compartment 33 that functionally corresponds to the insertion area 16 . The recording compartment can, like figure 9 illustrated, be open at the top or designed as an insertion channel.

Another important variation of the inventive concept is illustrated figure 10 . The tube bending device 8 is designed there as a reusable component of a disposable instrument 2 . The hose kink device 8 contains the actuating device 22 and is detachably connected to the handle of the instrument 2. In the connected state, the movable element 23 of the actuating device 22 can protrude into the disposable component and act there on the loop 12 in order to kink or release it. The control of the actuating device 22 takes place via a corresponding control connection to the control device 7, for example via a line that is not illustrated in any more detail.

According to the concept according to the invention, a kinked hose valve is provided for generating a high-pressure pulse, which includes a loop 12 provided in the supply hose (fluid hose 5) of an instrument 2 and a hose buckling device 8 provided as a reusable component. Such a valve has a very simple structure and allows the generation of very steep pressure rise flanks at very high pressures of up to 100 bar, as are required for needle-free injection. The sterilization effort is minimal. Likewise, the cost of materials is minimal when using disposable components.

References:

1

Furnishings

2

instrument

3

first fluid source

4

fluid applicator

5

first fluid hose

6

Plug

7

control device

8th

hose kink device

9

second fluid hose

10

second fluid source

11

holder

11a

partial housing

12

Ribbon

13, 14

12 loop leg

15

loop head

16

insertion area

17

opening

18

front wall

19

positioning means

20, 21

pencils

22

actuating device

23

moving element

24

drive device

25

element

26

attack

27

Kitchen sink

28

anchor

29

Feather

30

cam disk

31

return

32

Device

33

receiving compartment

Claims (15)

Instrument (2) with a fluid applicator (4), a first fluid tube (5), which extends from a proximal end that can be connected to a first fluid source (3) to the fluid applicator (2), with a holder (11) which is arranged on the first fluid hose (5) in order to hold it in a loop (12). Instrument according to Claim 1, characterized in that the fluid applicator (4) has a second fluid hose (9) which can be connected to a second fluid source (10) at its proximal end (9a). Instrument according to Claim 2, characterized in that the second fluid hose (9) extends from its proximal end (9a) without kinks or loops to the fluid applicator (4). Instrument according to one of the preceding claims, characterized in that the loop (12) has a length (L) which is greater than its width (B). Instrument according to one of the preceding claims, characterized in that the loop (12) has two legs (13, 14) held parallel to one another in the holder (11). Instrument according to one of the preceding claims, characterized in that the loop (12) is held immovably in the holder (11). Instrument according to one of the preceding claims, characterized in that the holder (11) has at least one connecting means (20, 21) for connection to a hose bending device (8). Instrument according to one of the preceding claims, characterized in that the instrument (2) is designed as a disposable instrument. hose kink device (8) with an insertion area (16) into which a loop (12) of a fluid hose (5) can be inserted in an insertion direction, with an actuating device (22) arranged on the tuck-in area (16) for controllably deforming or releasing the loop (12). Hose kinking device according to Claim 9, characterized in that the insertion area (16) has a slit cross-section. Hose kinking device according to one of Claims 9 or 10, characterized in that it has positioning means (19) for fixing the position of the loop (12) relative to the actuating device (22). Hose kinking device according to one of Claims 9 to 11, characterized in that the positioning means (19) is a stop (26) arranged behind the actuating device (22) in the insertion direction. Hose bending device according to one of Claims 9 to 11, characterized in that the positioning means (19) is a plug stop (18) arranged in front of the actuating device (22) in the insertion direction (). Hose bending device according to one of Claims 9 to 13, characterized in that the hose bending device (8) is designed as a sterilizable device. Device comprising an instrument (2) according to one of Claims 1 to 8 and a hose bending device (8) according to one of Claims 9 to 14.

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